Clinical Policy: Dexlansoprazole (Dexilant) Reference Number: HIM.PA.05 Effective Date: 01.01.20 Last Review Date: 02.20 Revision Log Line of Business: HIM See Important Reminder at the end of this policy for important regulatory and legal information. Description Dexlansoprazole (Dexilant®) is a proton pump inhibitors (PPI). FDA Approved Indication(s) Dexilant is indicated in patients 12 years of age and older for: Healing of all grades of erosive esophagitis (EE). Maintenance of healed EE and relief of heartburn. Treatment of symptomatic non-erosive gastroesophageal reflux disease (GERD). Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria. It is the policy of health plans affiliated with Centene Corporation® that Dexilant is medically necessary when the following criteria are met: I. Initial Approval Criteria A. All Indications (must meet all): 1. Prescribed for one of the following uses (a – e): a. Symptomatic GERD, including heartburn or laryngopharyngeal reflux; b. Esophageal complications of GERD (e.g., erosive esophagitis, esophageal stricture, Barrett’s esophagus, and Schatzki’s ring); c. Extra-esophageal complications (e.g., laryngopharyngeal reflux, vocal cord damage/nodules, asthma, laryngitis and pharyngitis); d. Peptic ulcer disease (e.g., gastric ulcers, duodenal ulcers, H. pylori and Zollinger- Ellison Syndrome); e. Gastrointestinal bleed prophylaxis for NSAID use and member meets at least one of the following (i, ii, or iii): i. History of peptic ulcer disease; ii. Age ≥ 60 years; iii. Concurrent therapy with anticoagulants (e.g., warfarin, aspirin, clopidogrel) or oral corticosteroids (e.g., prednisone); 2. Failure of lansoprazole, omeprazole, and pantoprazole, at up to maximally indicated doses, unless contraindicated or clinically significant adverse effects are experienced; 3. Dose does not exceed 60 mg (1 capsule) per day. Approval duration: 12 months Page 1 of 6 CLINICAL POLICY Dexlansoprazole B. Other diagnoses/indications 1. Refer to the off-label use policy for the relevant line of business if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized): HIM.PHAR.21 for health insurance marketplace II. Continued Therapy A. All Indications in Section I (must meet all): 1. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; 2. Member is responding positively to therapy; 3. If request is for a dose increase, new dose does not exceed 60 mg (1 capsule) per day. B. Other diagnoses/indications (must meet 1 or 2): 1. Currently receiving medication via Centene benefit and documentation supports positive response to therapy. Approval duration: Duration of request or 12 months (whichever is less); or 2. Refer to the off-label use policy for the relevant line of business if diagnosis is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized): HIM.PHAR.21 for health insurance marketplace III. Diagnoses/Indications for which coverage is NOT authorized: A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – HIM.PHAR.21 for health insurance marketplace or evidence of coverage documents IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration Appendix B: Therapeutic Alternatives This table provides a listing of preferred alternative therapy recommended in the approval criteria. The drugs listed here may not be a formulary agent for all relevant lines of business and may require prior authorization. Drug Name Dosing Regimen Dose Limit/ Maximum Dose pantoprazole Short-term treatment of erosive 40 mg/day (240 mg/day tablets and esophagitis associated with GERD for pathological suspension Adult and pediatric (age ≥ 5 years and hypersecretory (Protonix®) weight ≥ 40 kg): 40 mg PO QD conditions) Pediatric (age ≥ 5 years and weight ≥ 15 kg to < 40 kg): 20 mg PO QD Maintenance of healing of erosive esophagitis 40 mg PO QD Page 2 of 6 CLINICAL POLICY Dexlansoprazole Drug Name Dosing Regimen Dose Limit/ Maximum Dose Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome 40 mg PO BID omeprazole Duodenal ulcer 40 mg/day (360 mg/day capsules 20 mg PO QD for pathological (Prilosec®) hypersecretory Symptomatic GERD; Erosive conditions) esophagitis (treatment and maintenance) Adult: 20 mg PO QD Pediatric (age 1 to 16 years): Weight 5 kg to < 10 kg: 5 mg Weight 10 kg to < 20 kg: 10 mg Weight ≥ 20 kg: 20 mg Pediatric (age 1 month to < 1 year): Weight 5 kg to < 10 kg: 5 mg Weight ≥ 10 kg: 10 mg H. pylori Triple therapy: 20 mg PO BID for 10 days, in combination with amoxicillin and clarithromycin Dual therapy: 40 mg PO QD for 14 days, in combination with clarithromycin 40 mg/day Gastric ulcer 40 mg PO QD Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome 60 mg PO QD to 80 mg/day PO in divided doses lansoprazole Duodenal ulcers, risk reduction of 30 mg/day (180 mg/day capsules NSAID-associated gastric ulcer, for pathological (Prevacid®) maintenance of healing of erosive hypersecretory esophagitis conditions) 15 mg PO QD Short-term treatment of symptomatic GERD and erosive esophagitis Adult: 15 to 30 mg PO QD Pediatric (age 1 to 11 years): Weight > 30 kg: 30 mg PO QD Page 3 of 6 CLINICAL POLICY Dexlansoprazole Drug Name Dosing Regimen Dose Limit/ Maximum Dose Weight ≤ 30 kg: 15 mg PO QD Pediatric (age 12 to 17 years): Non-erosive GERD: 15 mg Erosive esophagitis: 30 mg H. pylori Triple therapy: 30 mg PO BID for 10 or 14 days in combination with amoxicillin and clarithromycin Dual therapy: 30 mg PO TID for 14 days in combination with amoxicillin Benign gastric ulcer, healing of NSAID- associated gastric ulcer 30 mg PO QD Pathological hypersecretory conditions, including Zollinger-Ellison Syndrome 60 mg PO QD Therapeutic alternatives are listed as Brand name® (generic) when the drug is available by brand name only and generic (Brand name®) when the drug is available by both brand and generic. Appendix C: Contraindications/Boxed Warnings Contraindication(s): o Hypersensitivity (e.g., to drug or other PPIs, substituted benzimidazoles, or to any components of the formulation) o Coadministration with rilpivirine-containing products Boxed warning(s): none reported V. Dosage and Administration Indication Dosing Regimen Maximum Dose Healing of erosive esophagitis 60 mg PO QD 60 mg/day Maintenance of healed erosive esophagitis and 30 mg PO QD 30 mg/day relief of heartburn; Symptomatic non-erosive GERD VI. Product Availability Delayed-release capsule: 30 mg, 60 mg VII. References 1. Dexilant Prescribing Information. Deerfield, IL: Takeda Pharmaceuticals; June 2018. Available at: https://general.takedapharm.com/DEXILANTPI. Accessed December 4, 2019. Page 4 of 6 CLINICAL POLICY Dexlansoprazole Reviews, Revisions, and Approvals Date P&T Approval Date Policy created per SDC adapted from HIM.PA.109 Step Therapy 12.04.19 02.20 policy which previously required failure of two of the following: lansoprazole, omeprazole, pantoprazole, or rabeprazole; revised redirection to three of three (lansoprazole, omeprazole, pantoprazole). Important Reminder This clinical policy has been developed by appropriately experienced and licensed health care professionals based on a review and consideration of currently available generally accepted standards of medical practice; peer-reviewed medical literature; government agency/program approval status; evidence-based guidelines and positions of leading national health professional organizations; views of physicians practicing in relevant clinical areas affected by this clinical policy; and other available clinical information. The Health Plan makes no representations and accepts no liability with respect to the content of any external information used or relied upon in developing this clinical policy. This clinical policy is consistent with standards of medical practice current at the time that this clinical policy was approved. “Health Plan” means a health plan that has adopted this clinical policy and that is operated or administered, in whole or in part, by Centene Management Company, LLC, or any of such health plan’s affiliates, as applicable. The purpose of this clinical policy is to provide a guide to medical necessity, which is a component of the guidelines used to assist in making coverage decisions and administering benefits. It does not constitute a contract or guarantee regarding payment or results. Coverage decisions and the administration of benefits are subject to all terms, conditions, exclusions and limitations of the coverage documents (e.g., evidence of coverage, certificate of coverage, policy, contract of insurance, etc.), as well as to state and federal requirements and applicable Health Plan-level administrative policies and procedures. This clinical policy is effective as of the date determined by the Health Plan. The date of posting may not be the effective date of this clinical policy. This clinical policy may be subject to applicable legal and regulatory requirements relating to provider notification. If there is a discrepancy between the effective date of this clinical policy and any applicable legal or regulatory requirement, the requirements of law and regulation shall govern. The Health Plan